Why the study?
The study aimed to characterize reporting patterns and non-treatment drug safety signals for diabetes insipidus in FAERS, evaluate signal stability using disproportionality methods, and assess reproducibility in JADER.
Do non-treatment drugs increase the reporting of diabetes insipidus in pharmacovigilance databases?
Population
3,444 FAERS and 696 JADER diabetes insipidus reports
Comparison
Non-treatment primary suspect drugs vs non-events or other reports
Design
Pharmacovigilance disproportionality analysis across FAERS and JADER databases
Key result
Lithium demonstrated the strongest disproportionality signal for diabetes insipidus (ROR 483.85), with dexmedetomidine, sevoflurane, and hydrocortisone also showing significant associations.
Authors
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May warrant vigilance for diabetes insipidus with nervous system and antineoplastic agents; hypothesis-generating from disproportionality signals and requires prospective confirmation.
Observational (n=20,550,043)
Do non-treatment drugs increase the reporting of diabetes insipidus in pharmacovigilance databases?
Odds Ratio: 483.85 (95% CI 437.94–534.58)
Several non-treatment drugs, particularly nervous system, antineoplastic/immunomodulating, and systemic hormonal agents, showed persistent disproportionality signals for diabetes insipidus in FAERS, serving as hypothesis-generating signals.
Li et al. (2026) conducted an observational in Diabetes insipidus (n=20,550,043). Lithium and other non-treatment primary suspect drugs vs. All other reports in the database (non-cases) was evaluated on Disproportionality signal for diabetes insipidus (Reporting Odds Ratio) (ROR 483.85, 95% CI 437.94-534.58). Lithium demonstrated the strongest disproportionality signal for diabetes insipidus (ROR 483.85), with dexmedetomidine, sevoflurane, and hydrocortisone also showing significant associations.